Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Friday, May 23, 2014

Let Harmed Patients In: End 'deny-and-defend'!


Cheryl Clark, for HealthLeaders Media , May 22, 2014

Patients who have been harmed by medical errors, and their family members, could be recruited to hospital internal quality review proceedings and their suffering could be used to prevent future mistakes. It's a good, but potentially disastrous idea.
Hospital quality expert R. Adams Dudley, MD, was flapping his official UCSF identification badge that hung from a lanyard around his neck. He told the group at a recent patient safety meeting that when a hospital patient is harmed, "maybe they and their families should be given one of these."
The point he was trying to make was this:
It's not enough for healthcare providers to merely be honest and apologize when a patient suffers harm, a strategy slowly replacing the standard "deny-and-defend" practice that persists in most hospitals, he says.
And it's not enough to do the thorough root cause analysis, even offering compensation right away, which some organizations are starting to do to avoid litigation and help patients grapple with the tragedy.
They need to do more if they're truly serious about being honest and preventing errors going forward, and this is what Dudley thinks might be the next step to take.
"What if, when someone is harmed in our hospitals, we say not only, 'we're sorry you were harmed', but 'here's a badge. Now you're part of our team. Now, if you choose, you can be a patient advocate, come to our staff meetings, talk about what happened, [and] attend patient safety conferences. We'll e-mail you the meeting schedule.'"
We want you to help tell us how we can prevent this from happening to someone else, he says.

'They Know We Messed Up'

"What better way for us to open ourselves to really, truly be transparent than to say that the people we let watch us should be the ones who know we can mess up, because we messed up with them?"
Dudley's patient badge isn't figurative. It should be a real piece of plastic that lets these patients and their families inside the hospital's inner sanctum, so they may walk the halls with the doctors and nurses. It's important symbolically and psychologically, he acknowledges.
"If we really believe that we [as providers] should be held accountable, why wouldn't we be willing to talk about these issues in front of the people who no doubt feel a strong need to check us out?"
But what if patients and their families see providers arguing with each other about what went wrong, pointing fingers to assign blame? Wouldn't it be a bad idea to allow patients or their families to see that discord?
Not at all, Dudley says.
"If one specialist thinks one thing, and another thinks another, there's no reason to hide that. That's just part of medicine. It happens all the time." It's part of the process of getting to the truth, he says.
Dudley, founder of the California Hospital Assessment and Reporting Task Force (CHART) and many other research initiatives geared to performance improvement, is known for his sometimes unconventional ideas. He acknowledges that many hospital officials will write them off as just more craziness from California's wacky healthcare system, he jokes.

But increasingly, this idea is taking off in a few places, although not quite as intimately as Dudley describes. Patients and their family members are being recruited in very public ways to the patient safety movement —although rarely inside the hospital's often tense and internecine adverse event review committees —to use their experiences to help fix flaws in the system.
Former Patient Outsiders Are Now Insiders
Helen Haskell of Mothers Against Medical Error, whose son died from one, now sits on numerous national safety panels. The parents of Rory Staunton, the 12-year-old who died of sepsis that a New York hospital failed to recognize, began a working relationship with state regulators and the Centers for Disease Control and Prevention to increase sepsis early detection. 

Then there's ePatient Dave, MRSA survivor Jeanine Thomas and dozens of other national examples of outsiders who are now insiders.
Of course, there's a point at which this could be a disaster, accomplishing the opposite of its intent, provoking nonproductive disruption from patients and family members who are still too angry and confused to make cogent contributions. Dudley acknowledges that he hasn't even proposed the idea yet to UCSF, although he might.
Because of that concern, I ran the idea by attorney Richard Boothman, chief risk officer and director for clinical safety at the 925-bed University of Michigan Health System. In 2001, Boothman replaced what he says was the classic "deny-and-defend" model for responding to adverse events with "the Michigan Model," in which patients are told up front what happened, followed by three specific actions:
1.              Compensate patients quickly and fairly when unreasonable medical care caused injury.
2.              If the care was reasonable or did not adversely affect the clinical outcome support caregivers and the organization vigorously. (A child with an ear infection who has a severe reaction to an appropriate antibiotic)
3.              Reduce patient injuries [and therefore claims] by learning through patients' experiences.

The result, published in the Annals of Internal Medicine in August, 2010, was that the average rate of new claims dropped from 7.03 to 4.52 per 100,000 patient encounters and the rate of lawsuits dropped from 2.13 to .75.
Also, median time from claim reporting to resolution dropped from 1.36 years to .95 years. And costs incurred for paying total liability, patient compensation, and non-compensation-related legal costs all declined, from $405,921 per lawsuit before the program was implemented to $228,308 after, a trend that persists.
But Boothman, who attended the same patient safety meeting where Dudley waved his badge, says, "It sounds great until you try it." UMHS did try it a year ago and encountered two insurmountable problems.
First, he says, "there's a practical problem that hit us right in the chops. When something bad happens, the clock starts ticking, and we have an immediate need to do our investigation to understand what happened so no one else gets hurt.
But patients are dealing with new medical needs, or sometimes they [or family members] are grieving. It sometimes takes them six months before they can talk with us, and I can't wait six months. I won't put other patients at risk."
Second, UMHS found "nobody will be honest unless they feel they're in a safe place. You have to create an environment where people can speculate, sometimes offer wild ideas about what happened."

He gives this real UMHS example: "A doctor operated on the wrong spine level, and during the event review everyone involved—doctors, nurses, techs—were in one room going minute by minute to figure out what happened. Afterwards, two nurses called me in tears saying 'You never got the truth.
"That surgeon was working in two different operating rooms at one time, and the residents were in over their heads. The surgeon got disoriented and operated on the wrong level.' "
"Well, why didn't you say anything?" Boothman asked them.
They didn't dare, they replied. "The surgeon was sitting across from us."
That's the problem, Boothman says. "If you put a grieving angry patient in a room like that and expect anyone will speak openly, it will never happen."
I like Dudley's idea because I think patients who believe they've suffered a hospital-caused harm see the system suddenly pivot against them.
Where before they may have felt important and secure, now they see backs turned and calls unanswered. The idea of letting them inside, making them members of this special club so they won't feel abandoned and victimized, and litigious, seems like it couldn't hurt.
But maybe there have to be limits to how far providers actually let them in.


Cheryl Clark is senior quality editor and California correspondent for HealthLeaders Media. She is a member of the Association of Health Care Journalists.

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